MEDLINE DYND44110Recalls & reported problems
Medline Industries, Inc. · TRAP,MUCUS, 10FR, DELEE, W/VALVE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196997404), received between Jun 12, 2024 and Sep 12, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Decrease in Suction3
- Suction Problem2
- Fluid/Blood Leak1
- Material Integrity Problem1
- Material Too Soft/Flexible1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746302 ↗OtherSep 10, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722597 ↗MalfunctionAug 28, 2026Material Too Soft/Flexible
It was reported that the device is flimsy and not able to advance into airway to suction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506048 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240256 ↗MalfunctionApr 13, 2026Decrease in Suction
ACCORDING TO THE CUSTOMER, ON (B)(6) 2026, "DURING DELIVERY, AN INFANT WAS BEING SUCTIONED, AND THE TEAM COULD NOT GET AN APPROPRIATE SUCTION WHEN THE DELEE WAS ATTACHED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861135 ↗MalfunctionApr 11, 2026Decrease in Suction
ACCORDING TO THE CUSTOMER, ON (B)(6) 2026, "DURING DELIVERY, AN INFANT WAS BEING SUCTIONED, AND THE TEAM COULD NOT GET AN APPROPRIATE SUCTION WHEN THE DELEE WAS ATTACHED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24848043 ↗MalfunctionDec 29, 2025Suction Problem; Suction Failure; Suction Problem; Suction Failure
ACCORDING TO THE CUSTOMER, "THE SUCTION CATHETER DID NOT WORK WHEN NEEDED FOR INFANT RESUSCITATION. MULTIPLE SUCTION CATHETERS HAVE TO BE USED WHEN THESE DON'T PROVIDE SUCTION."
Patient problems: Insufficient Information
MAUDE report 23908513 ↗InjuryJun 12, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, "DURING A NEONATAL RESUSCITATION, THE DELEE SUCTION DID NOT WORK PROPERLY."
Patient problems: Insufficient Information
MAUDE report 19524275 ↗
Other TRAP, STERILE SPECIMEN devices
- Medline ReNewal N2FOURPORTRMedline Industries, Inc. · TRAP, STERILE SPECIMEN3 reports
- MEDLINE DYND44108Medline Industries, Inc. · TRAP, STERILE SPECIMEN2 reports
- Medline DYND44180Medline Industries, Inc. · TRAP, STERILE SPECIMEN1 report
- N/a 5400-800-000Stryker Corporation · TRAP, STERILE SPECIMEN1 report
- Medline DYND44140Medline Industries, Inc. · TRAP, STERILE SPECIMEN1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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